Intestinal Infectious DiseasesNCT03161951
Differential Diagnostics of Etiology of Acute Infections
An observational study of Intestinal Infectious Diseases and Neuroinfections, run by The Republican Research and Practical Center for Epidemiology and Microbiology.
Trial summary
Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Infectious Diseases, Neuroinfections
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2017to 29 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the infectious departments of city hospitals.
Who may be able to join
- neuroinfections or acute intestinal infections;
- the possibility of blood sampling within a period of up to 24 hours from the moment of admission to hospital;
- less than 72 hours passed after the onset of the disease and until blood was collected;
Who cannot join
- refuse of patient to participate in the trial;
- more than 24 hours passed after the patient entered the hospital;
- the disease began more than 72 hours ago;
- concomitant severe acute and chronic diseases;
- malignant neoplasms, treatment at a time of less than 1 year, autoimmune diseases in the phase of exacerbation;
- pregnancy/lactation;
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- HIV, Hepatites B/C;
- active tuberculosis;
- alcohol use disorder/drug addiction.
About this study
Official title: Differential Diagnostics of Etiology of Acute Infections Based on the Analysis of Expression of Activation Markers on the Surface of Peripheral Blood Monocytes and Neutrophils.
Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.
Read the detailed description
During the study, method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.This method will allow to make a diagnosis within an hour after blood sampling.
The expression of the following markers of activation will be studied using flow cytometry: CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and HLA-DR.
- Conditions
- Intestinal Infectious Diseases, Neuroinfections
- Keywords
- acute Infections, flow cytometry, cell activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuroinfections | Patients with acute neuroinfections of bacterial and viral ethology. | |
| Intestinal Infectious Diseases | Patients with acute intestinal infectious diseases of bacterial and viral ethology. | |
| Control group | Control group of healthy persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the diagnosis of bacterial vs viral acute infection
Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method
Measured: 1 month
Specificity of the diagnosis of bacterial vs viral acute infection
Specificity of the diagnosis of bacterial vs viral acute infection using proposed method
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start3 Jan 2017
- Primary completion10 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
- Investigators
- Andrei Y Hancharou, Dr, Study director, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161951
- Sponsor's protocol ID
- RRPCEM_NMAT
- Status last verified
- Jan 2019
- First submitted
- 17 May 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnostics of Etiology of Acute Infections Based on the Analysis of Expression of Activation Markers on the Surface of Peripheral Blood Monocytes and Neutrophils.
- ClinicalTrials.gov ID
- NCT03161951
- Acronym / sponsor ID
- RRPCEM_NMAT
- Conditions
- Intestinal Infectious Diseases, Neuroinfections
- Keywords
- acute Infections, flow cytometry, cell activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.
Detailed description
During the study, method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.This method will allow to make a diagnosis within an hour after blood sampling.
The expression of the following markers of activation will be studied using flow cytometry: CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and HLA-DR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuroinfections | – | –Patients with acute neuroinfections of bacterial and viral ethology. |
| Intestinal Infectious Diseases | – | –Patients with acute intestinal infectious diseases of bacterial and viral ethology. |
| Control group | – | –Control group of healthy persons |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the infectious departments of city hospitals.
Key inclusion criteria (3 listed)
- neuroinfections or acute intestinal infections;
- the possibility of blood sampling within a period of up to 24 hours from the moment of admission to hospital;
- less than 72 hours passed after the onset of the disease and until blood was collected;
Key exclusion criteria (9 listed)
- refuse of patient to participate in the trial;
- more than 24 hours passed after the patient entered the hospital;
- the disease began more than 72 hours ago;
- concomitant severe acute and chronic diseases;
- malignant neoplasms, treatment at a time of less than 1 year, autoimmune diseases in the phase of exacerbation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of the diagnosis of bacterial vs viral acute infection
Time frame: 1 month
Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method
Specificity of the diagnosis of bacterial vs viral acute infection
Time frame: 1 month
Specificity of the diagnosis of bacterial vs viral acute infection using proposed method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Y Hancharou, Dr study director
Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Infectious Diseases and Neuroinfections, run by The Republican Research and Practical Center for Epidemiology and Microbiology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the diagnosis of bacterial vs viral acute infection (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.